Father Inclusive Prenatal Care for Pregnancy

(FIPC Trial)

Overseen By Wrenetha A Julion, PhD, MPH, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-English/Spanish, Cognitive disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Father Inclusive Prenatal Care for Pregnancy?

Research shows that involving fathers in prenatal care can have positive effects on maternal and child health, and reduce obesity risk. Engaging fathers early in the prenatal period is linked to long-term benefits for children, and using digital tools to involve fathers in prenatal health has shown promise in improving pregnancy outcomes. ^{1 2 3 4 5}

What makes the Father Inclusive Prenatal Care treatment unique?

Father Inclusive Prenatal Care is unique because it actively involves fathers in prenatal care, which is not common in traditional prenatal programs. This approach aims to improve outcomes for both the mother and child by fostering early paternal engagement and support. ^{1 2 3 6 7}

What is the purpose of this trial?

Young families need additional institutional support to help them meet the challenges of parenthood. Prenatal clinics are well situated to address some of their needs by expanding services to include fathers. The Father Inclusive Prenatal Care (FIPC) model is designed to prepare young men for the challenges of parenting by supporting the development of their relationship skills as part of routine prenatal healthcare. This approach involves assessing expectant fathers and mothers with a "parent prep-check" (PPC) to identify their needs and then offer services to address those needs and prepare them for parenthood. Services include: (1) parent education about how to understand and care for infants, and how to build secure parent-child bonds; (2) an evidence-based co-parenting program to strengthen and stabilize their family; and (3) educational and employment support designed to help young parents find and keep living wage jobs. The project will be implemented through several community based healthcare sites that are well positioned to engage young fathers through their prenatal clinics. To extend the reach and accessibility of the model, trainings and most services will be available online. As a result of participating in this project it is expected that young couples will have better co-parenting relationships and be better prepared to take care of their infants.

Research Team

Wrenetha A Julion, PhD, MPH, RN, CNL, FAAN

Principal Investigator

Rush University Medical Center

Paul w Florsheim, PhD

Principal Investigator

University of Wisconsin, Milwaukee

Eligibility Criteria

This trial is for first-time pregnant women and their partners who are willing to participate together in an interview. It's not open to those who don't speak English or Spanish, or have cognitive disabilities that affect understanding of the consent process.

Inclusion Criteria

My partner and I are willing to participate in the initial interview together.

I am a pregnant woman who has never given birth.

Exclusion Criteria

Men and Women with language other than Spanish or English and cognitive disability interfering with ability to understand the informed consent process.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Parent Prep Check (PPC)

Engagement of young fathers and mothers in research and intervention activities, including a semi-structured interview and motivational interviewing approach

3 hours

1 visit (in-person)

Father Inclusive Prenatal Care (FIPC) Program

Participants receive co-parenting, parenting education, and employment and educational readiness training and support

6 months

Multiple visits (online and in-person)

Follow-up

Participants are monitored for relationship quality, emotional intelligence, parenting stress, and paternal involvement at 6 and 18 months post birth

18 months

Follow-up assessments at 6 and 18 months post birth

Treatment Details

Interventions

• Father Inclusive Prenatal Care

Trial Overview The study tests a Father Inclusive Prenatal Care model aimed at preparing young men for parenting by enhancing relationship skills within routine prenatal care. This includes parent education, co-parenting programs, and support with education and employment.

Participant Groups

Group I: Father Inclusive Prenatal Care Experimental Treatment 1 Intervention

Co parenting, parenting education, employment and educational readiness training and support.

Father Inclusive Prenatal Care is already approved in United States for the following indications:

Approved in United States as FIPC for:

• Supporting young families in prenatal care
• Improving co-parenting relationships
• Preparing young parents for parenthood

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Skills for Chicagoland's Future-Chicago

Collaborator

Trials

1

Recruited

250+

Parent Child Center (PCC) Community Wellness Center

Collaborator

Trials

1

Recruited

250+

Children's Bureau - Administration for Children and Families

Collaborator

Trials

23

Recruited

40,900+

Advocate Health Care

Collaborator

Trials

57

Recruited

1,412,000+

University of Wisconsin, Milwaukee

Collaborator

Trials

52

Recruited

6,200+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Findings from Research

A structured engagement study involving community leaders and new fathers was conducted to inform the development of a father-inclusive intervention for infant obesity prevention, highlighting the importance of including fathers in health initiatives.

Feedback from stakeholders revealed that tailoring program delivery to address the specific social-emotional needs of new parents can enhance the effectiveness of obesity prevention efforts, ultimately leading to better health outcomes for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. Silver, SR., Whooten, RC., Kwete, GM., et al.[2022]

Paternal involvement in prenatal care is crucial and can lead to positive long-term outcomes for children, emphasizing that fathers play an important role from conception through pregnancy and beyond.

The paper suggests that clinicians should actively promote and encourage fathers' engagement in prenatal care to foster responsibility and support for both the mother and child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatherlessness Begins Prenatally: A Scoping Review. Sandler, R.[2023]

The family-centred consultation approach in postnatal care was found to be effective, helping both mothers and fathers feel more secure and confident in managing their new roles with their baby.

Fathers reported feeling included in the postnatal care process from the start, highlighting the importance of family nursing in promoting involvement and support for both parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Young first-time parents' experiences with family-centred postpartal health care in Switzerland]. Kläusler-Troxler, M., Kurth, E., Spirig, R.[2014]

The Family Integrated Care (FICare) program in Alberta's NICUs positively influenced the experiences of fathers of preterm infants, enhancing their confidence and involvement during their infants' hospital stay and beyond.

Fathers reported feeling more supported and engaged due to effective communication and the opportunity to identify their roles, suggesting that FICare can lead to better family dynamics and parenting experiences after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fathers' Experiences in Alberta Family Integrated Care: A Qualitative Study. Shafey, A., Benzies, K., Amin, R., et al.[2023]

A study involving 962 adult males showed that men recognize the importance of being involved in prenatal health, despite facing barriers like time constraints and unclear roles.

The majority of participants found an eHealth app for new and expectant fathers useful and expressed a desire for more interactive features, indicating a strong acceptance of digital tools to engage men in supporting healthy pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Men in Prenatal Health via eHealth: Findings From a National Survey. Mackert, M., Guadagno, M., Lazard, A., et al.[2020]

Experienced community interventionists, even without formal couples' therapy training, can effectively deliver a manualized prenatal intervention to unmarried parents, achieving acceptable levels of fidelity in their sessions.

Parents reported satisfaction with the intervention and showed significant improvements in family dynamics three to four months after treatment, highlighting the importance of involving fathers in prenatal coparenting support, even in non-cohabiting situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prenatal Coparenting Intervention With Unmarried Father-Mother Dyads: Fidelity of Intervention Delivery by Male-Female Community Mentor Teams. Salman-Engin, S., Little, T., Gaskin-Butler, V., et al.[2018]

The PRENACEL program, which uses SMS technology to provide health education to partners of pregnant women, significantly increased their participation in prenatal consultations and support during childbirth compared to control groups.

With a 53.4% adherence rate, the program demonstrated good acceptability and suggests that communication technology can effectively enhance men's involvement in prenatal and postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRENACEL partner - use of short message service (SMS) to encourage male involvement in prenatal care: a cluster randomized trial. Bonifácio, LP., Franzon, ACA., Zaratini, FS., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Stakeholder engagement in developing a father-inclusive early life obesity prevention intervention: First Heroes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Fatherlessness Begins Prenatally: A Scoping Review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Young first-time parents' experiences with family-centred postpartal health care in Switzerland]. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Fathers' Experiences in Alberta Family Integrated Care: A Qualitative Study. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Engaging Men in Prenatal Health via eHealth: Findings From a National Survey. [2020]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A Prenatal Coparenting Intervention With Unmarried Father-Mother Dyads: Fidelity of Intervention Delivery by Male-Female Community Mentor Teams. [2018]

7. England pubmed.ncbi.nlm.nih.gov

PRENACEL partner - use of short message service (SMS) to encourage male involvement in prenatal care: a cluster randomized trial. [2021]